|Publication number||US7875020 B2|
|Application number||US 12/467,873|
|Publication date||Jan 25, 2011|
|Filing date||May 18, 2009|
|Priority date||Aug 22, 2002|
|Also published as||EP1391219A2, EP1391219A3, US7081109, US20040039374, US20070078443, US20090306628|
|Publication number||12467873, 467873, US 7875020 B2, US 7875020B2, US-B2-7875020, US7875020 B2, US7875020B2|
|Inventors||Gerry Tighe, Brian Eugene Baldwin, Joseph V. Ranalleta|
|Original Assignee||Baxa Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (50), Non-Patent Citations (1), Referenced by (2), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation application of U.S. patent application Ser. No. 11/433,064 filed May 11, 2006, which is a divisional application of U.S. patent application Ser. No. 10/226,183 filed Aug. 22, 2002, now U.S. Pat. No. 7,081,109, issued on Jul. 25, 2006. Each of the foregoing is incorporated herein by reference in its entirety.
The present invention relates to the field of medical liquid administration, and more particularly, to a docking apparatus and method for enhancing the maintenance of sterility of a male luer connector fluidly interconnected or interconnectable to a medical liquid source during one or repeated periods of non-use (e.g. between successive administrations of a medical liquid through a vascular catheter over an extended time period).
Numerous techniques are employed for the administration of “medical liquids” (e.g. liquid medication and flush solutions) to a patient. In particular, where repeated medication infusions are required, medical liquids are often administered via the use of a vascular access catheter that is fluidly interconnected or interconnectable to one or more medical liquid sources via an associated tubing line set. Typically, the catheter is inserted into the vein of a patient and left there for multiple intravenous (IV) infusions during an extended course of medication therapy. By way of example, the time period between IV drug infusions may be between about 4 to 24 hours, wherein the IV liquid medication source is typically replaced after each dose infusion. In the course of extended medication therapy a given tubing line set may be repeatedly employed, and a number of tubing line sets may be successively employed. For example, it is typical to replace a given tubing line set every two or three days.
In conjunction with extended therapy applications, a desirable practice is to disconnect a vascular catheter from a medical liquid source/tubing line set between infusions. In this regard, most patients receiving IV medication therapy are ambulatory to some degree and benefit from not being continuously connected to a medical liquid source/tubing line set.
To facilitate the ready and repeated connection/disconnection of a vascular catheter and medical liquid source/tubing line set, while avoiding the use of needle-type arrangements (e.g. arrangements where sharp/blunt needle ends are inserted into specialized vascular catheter connection ports having a pierceable/slit stopper), complimentary female and male luer connectors are often utilized. That is, a female luer connector is fluidly interconnected as an access port to the vascular catheter and a complimentary male luer connector is fluidly interconnected or readily interconnectable to the medical liquid source as part of the associated tubing line set. In order to maintain sterility, the male luer connector is typically covered with a new cap after each disconnection from the female luer connector, and the female luer connector is contacted with an antibacterial material (e.g. an alcohol solution) before each interconnection with the male luer connector. Such an approach entails the unpackaging, use and disposal of multiple caps over an extended medication therapy. For example, where liquid medication is administered at least every four hours over a three-day period at least 18 caps would be required to maintain the sterility of the male luer connector. As may be appreciated, cap-related costs, medical personnel time expenditures and inventory management implications associated with this approach can become quite significant.
In view of the foregoing, a broad objective of the present invention is to facilitate both the sterile and cost-effective handling of male luer connectors that are repeatedly interconnected/disconnected in the course of medical treatment, particularly in applications where multiple vascular catheter interconnections/disconnections with a medical liquid source are entailed in the course of IV medication therapy.
A further goal of the present invention is to address the noted broad objective in a manner that actually reduces medical accessory costs, inventory management requirements and medical personnel time expenditures.
Yet another objective of the present invention is to provide for enhanced sterile handling of male luer connectors fluidly interconnected or interconnectable to medical liquid sources in a manner that is both convenient and space-efficient at a patient care site.
One or more of the above objectives and additional advantages are realized by the inventive apparatus and method disclosed herein. In particular, a dedicated apparatus is provided for docking a male luer connector that is fluidly interconnected or interconnectable to a medical liquid source during one or repeated periods of non-use. The apparatus comprises a holding receptacle, adapted for selective retentive engagement with a male luer connector, and a depressible member disposed in an internal chamber of the holding receptacle. More particularly, a top end of the depressible member is located in a single access opening to the internal chamber, wherein a nozzle of a male luer connector may be inserted into the single access opening to contact and depress the depressible member while being isolated inside the holding receptacle. In short, a simple yet effective apparatus of a dedicated nature is provided for repeated docking of a male luer connector, wherein the docking apparatus facilitates the maintenance of sterility of the male luer connector when docked.
In the later regard, the defined arrangement facilitates the application of an anti-bacterial material to a top surface of the depressible member prior to each occasion upon which a male luer connector is docked. For such purposes, the top surface is preferably disposed one of substantially coplanar with or slightly bulging outward relative to a surrounding rim of the holding receptacle prior to/after docking of a male luer connector. Further, the depressible member may be advantageously provided to substantially fill and seal the single access opening during periods of non-use (e.g. prior to and after docking), wherein the depressible member effectively isolates the internal chamber from contamination during such periods. Moreover, the top surface is preferably continuous across the lateral extent thereof, e.g. free from slits, pores or other liquid passageways therethrough.
To provide a depressible member having the desired attributes, the depressible member should be of a resilient nature, e.g. at least partially compressible and/or deflectable within the holding receptacle, and should display a relatively high memory. By way of example, the depressible member may be integrally defined by an elastomeric material (e.g. silicon rubber or rubber foam). Further, an interconnected top layer may be utilized to separately define the top surface of the depressible member (e.g. a polymeric film such Mylar). In another approach, the depressible member may comprise an elastomeric part at a top end and a wire spring (e.g. a coil spring) at a bottom end.
Preferably, the holding receptacle and the depressible member are configured so that the depressible member is retained, or captured, within the internal chamber of the holding receptacle. In one approach, the single access opening of the holding receptacle may have a cross-dimension that is less than a corresponding cross-dimension of the top end of the depressible member (e.g. an inward edge of a surrounding receptacle rim defining the opening may overlap an outer edge portion of the top end of the depressible member). In another approach, the internal chamber and the depressible member may be sized and otherwise configured to have complimentary sidewall portions which are larger in cross-section than their respective top ends, wherein the sidewalls of each interface to retain the depressible member within the holding receptacle. For example, the sidewalls of the depressible member and internal chamber may have complimentary shoulder portions (e.g. stepped-out), wherein the sidewalls of the internal chamber restrain the depressible member within the internal chamber of the holding receptacle.
As noted, the holding receptacle of the docking apparatus is adapted for retentive engagement with a male luer connector end. In a primary approach, such functionality may be provided by defining a female luer connector about the single access opening of the holding receptacle. That is, complementary threaded surfaces may be utilized to facilitate ready interconnection/disconnection upon relative rotational movement of a male luer connector and the holding receptacle. Further, the single access opening of the holding receptacle may be preferably sized and configured to sealably engage the outside surface of a tapered nozzle of a male luer connector inserted thereinto.
The inventive docking apparatus may further include at least one handling member extending away from the holding receptacle to facilitate grasping and manipulation of the docking apparatus. Specifically, a lateral handling member may be provided that extends about and laterally away from the holding receptacle. Preferably, top and bottom portions of the holding receptacle extend upward and downward, respectively, from a lateral handling member. As an alternative or in addition to the lateral handling member, a rearward handling member may be provided that extends rearwardly from the holding receptacle. The rearward handling member may be of fin-like configuration to facilitate grasping by the fingers of a user as the docking apparatus and a male luer connector are rotated relative to one another for interconnection/disconnection. To yield enhanced torque, the rearward handling member may be of a width that is greater than that of the holding receptacle.
In conjunction with the noted features, the inventive docking apparatus may also include at least one slot sized for selective supportive interconnection of the docking apparatus to a tubing line at a patient site. Preferably, at least two slots are provided, wherein a tortuous path for tubing line engagement is defined therebetween and/or wherein two slots restrain tubing line movement in different directions (e.g. side-to-side and up-and-down). Most preferably, a tortuous path is defined that extends through more than one plane.
In one approach, a lateral slot(s) may be defined between the bottom of a lateral handling member and an inverted T-shaped member that defines a bottom portion of the holding receptacle. In such approach, the T-shaped member may be interconnected to a cylindrical top member to combinatively define the holding receptacle, wherein the depressible member is disposed therebetween. Additionally, one or more leg slots may be provided between legs that extend from the bottom of the lateral handling member, wherein each leg slot is defined by a different pair of legs. In one arrangement, leg slots are provided between opposing legs at each end of the docking apparatus and an intermediate, ring-shaped lateral slot is provided around the bottom portion of a cylindrical holding receptacle, wherein a straight-180° curve-straight pathway is defined for tubing line interconnection.
In another approach, one or more leg slots may be provided together with one or a plurality of edge slots provided about the periphery of a lateral handling member. In one arrangement leg slots are provided at each end of the docking apparatus and two edge slots with an intermediate side bar are provided on each side of the docking apparatus, wherein a straight-90° curve-180° curve-90° curve-straight pathway is defined which extends in more than one plane. Further, the leg slots may be provided to extend through a lateral handling member, wherein a wide range of tubing line approach angles can be realized.
As may be appreciated, the present invention also provides an inventive method for handling a male luer connector interconnected or interconnectable to a medical liquid source in connection with medical liquid administration procedures. In the broadest sense, the method includes the steps of administering medical liquid from the medical liquid source and, after such administration, docking the male luer connector with a docking apparatus. In primary applications, the administering step may entail attaching the male luer connector to an access port that is fluidly interconnected to a patient's vascular system (e.g. via a vascular catheter), and detaching the male luer connector from the access port following medical liquid administration.
In conjunction with the docking step, the method may include the docking sub-steps of contacting a nozzle of the male luer connector with the top surface of a depressible member disposed within a holding receptacle of the docking apparatus, and interconnecting the male luer connector with the holding receptacle, wherein the nozzle depresses the depressible member and is isolated in the holding receptacle. For such purposes the holding receptacle preferable has a single access opening thereinto. When repeated administration of medical liquid from the source is desired, the method further includes the step of disconnecting the male luer connector from the holding receptacle, and successively repeating the administering, docking and disconnecting steps. As may be appreciated, when repeating the administering step the vascular catheter access port may be contacted with antibacterial material prior to attachment of the male luer connector. For such purposes, the access port is preferably of a swabbable female luer type.
The docking step may further include the sub-step of applying an anti-bacterial material on the top surface of the depressible member prior to the noted contacting sub-step. By way of example, the anti-bacterial material may be applied by simply swabbing the anti-bacterial material onto the top surface of the depressible material (e.g. utilizing gauze swabs or the like). Relatedly, the contacting sub-step may provide for the engagement of a leading edge of the male luer connector nozzle with the top surface of the depressible member across the substantial entirety of such leading edge. Further, the noted engagement (i.e. between the leading edge of the nozzle and the top surface of the depressible member) may preferably be maintained during docking (e.g. to seal the nozzle). In conjunction with the docking step, the method may also preferably provide for sealing engagement between the holding receptacle and outer surface of the male luer connector nozzle. More particularly, the single access opening of the holding receptacle may be sized and configured to slidably, matingly receive a tapered nozzle of the male luer connector during docking.
For purposes of completing the docking and/or disconnecting steps, the method may further provide for the grasping of a handling member interconnected to the holding receptacle. For example, a lateral handling member may be held by a user and/or a reward handling member may be gripped by a user during connection/disconnection, wherein the holding receptacle and male luer connector may be advanced into or retracted from interconnection. In a primary approach, at least one of the holding receptacle and male luer connector may be rotated relative to the other to obtain a threaded interconnection/disconnection therebetween. To enhance the convenience of use and otherwise maintain an orderly patient care site, the method may further include the step of attaching a handling member of the docking device to a tubing line present at a patient site. For such purposes, the tubing line may be positioned through one or a plurality of interconnection slots provided by the docking apparatus. In one approach, such positioning may entail the routing of the tubing line between interconnection slots that define a tortuous path that extends through at least one and preferably more than one plane.
Additional aspects and advantages of the present invention will become apparent to one skilled in the art upon consideration of the further description that follows.
As best shown by
To yield such an arrangement, the top end of depressible member 40 may be of a width that is less than a corresponding width of the single access opening of receptacle 20, wherein the inward edge of rim 22 captures the depressible member 40 in the internal chamber of the holding receptacle 20. Additionally, depressible member 40 may be of a length that is slightly greater than a depth of the internal chamber of holding receptacle 20, wherein the depressible member 40 may be slightly depressed as captured within holding receptacle 20 with the top surface 42 slightly bulged outward in the single access opening.
In this embodiment, the depressible member 40 may have an external configuration that is substantially coincident with the configuration of the internal chamber of holding receptacle 20. Further, the depressible member 40 may be sized to substantially fill the internal chamber. Specifically, the sidewalls 44 of depressible member 40 and internal sidewalls 24 of receptacle 20 may define substantially coincident cylindrical configurations as shown.
Certainly, other coincident configurations are possible, including configurations in which depressible member 40 and the internal chamber of holding receptacle 20 have coincident mid-portion or bottom-end widths which are greater than coincident top end widths. For example, such coincident configurations may include frusto-conical, or stepped-in sidewalls portions (e.g. to define coincident bottle-like configurations), wherein the depressible member 40 is captured in the internal chamber by restraining interface between the internal sidewalls of the holding receptacle 20 and external sidewalls of the depressible member 40.
In the illustrated embodiment, holding receptacle 20 is defined by a top member 26 and interconnected bottom member 28. By way of example, the top and bottom members 26, 28 may be provided for selective snap-fit engagement, wherein the depressible member 40 may be interposed therebetween prior to connection. In other arrangements, the top and bottom members 26, 28 may be hingedly interconnected or provided with complimentary threading for screw-type interconnection. Alternatively, receptacle 20 may be a one-piece construction, wherein depressible member 40 is forcibly inserted in a slightly depressed, or compressed, state upon assembly.
As may be appreciated, depressible member 40 should be of a resilient nature, wherein the depressible member 40 is capable of both being depressed during docking and returning to its initial configuration to substantially fill and seal the single access opening of holding receptacle 20 after docking. For example, in the embodiment of
The top surface 42 of the depressible member 40 may be integrally defined by a compressible material as described above. Alternatively, the top surface 42 may be defined by a top layer 46 adjoined to the top end of a main body. By way of example, the top layer may comprise a polymeric film (e.g. Mylar). In either case, the provision of a substantially continuous, non-porous top surface 42 facilitates the application of an anti-bacterial material thereto prior to docking of the apparatus 10 with a male luer connector.
For purposes of retentive docking, the top end of holding receptacle 20 should may be sized and preferably provided with external threads 30 that are compatible for selective threaded engagement with complimentary threads disposed on male luer connectors. Further, to facilitate sealed docking, the single access opening of the holding receptacle may be sized and configured to slidably, matingly receive a tapered nozzle of the male luer connector during docking. In this regard, docking apparatus 10 may be provided for universal use with any medical liquid source that is fluidly interconnected or interconnectable with a compatible male luer connector.
Referring further to
In this regard, docking apparatus 10 may include a number of slots sized and located for selective receipt of a tubing line. In particular, a lateral slot 70 may be provided on the bottom side of the lateral handling member 60. In the illustrated embodiment slot 70 is defined between the bottom side of lateral member 62 and a ring-shaped portion of the bottom member 28. In this regard, the bottom member 28 may have an inverted T-configuration (i.e. as interconnected to the top member 26). Legs 64 may also define leg slots 72 at each end of the docking apparatus 10. Such leg slots 72, together with lateral slot 70, may be sized to retainably engage and otherwise define a tortuous path for an interconnected tubing line.
More particularly, and with reference now to
Referring now to
As will be appreciated, the male luer connector 122 may be maintained in the illustrated docked position of
As shown in
As further shown by
The docking apparatus 310 may further include a lateral handling member 362 which having corner legs 364 interconnected thereto. The lateral handling member 362 extends about and laterally away from the sides of holding receptacle 320 to facilitate handling of the docking apparatus 310. In this embodiment, the handling member 360 is integrally defined with the bottom member 328 of the holding receptacle 320 (e.g. via plastic molding) and a top layer 360 may be secured (e.g. glued) on the lateral handling member 362. As shown, the top end of holding receptacle 320 extends upwardly from the lateral member 362 and the corner legs 364 and bottom end of holding receptacle 320 extend downwardly from the lateral member 362. A top side of the lateral member 362 may be provided with a peripheral rim 366.
Docking apparatus 310 may be provided with lateral slots 370 for selective receipt of a tubing line at a patient site. The lateral slots 370 are provided on a bottom side of the lateral handling member 360 between the bottom side of the lateral member 362 and wing-like projections 329 extending from opposing sides of the bottom member 328. As shown by
The male luer connector 122 may be maintained in the illustrated docked position of
In particular, docking apparatus 410 includes a holding receptacle 420 having an internal chamber with a depressible member 440 positioned within an internal chamber thereof. The depressible member 440 substantially fills a single access opening to the internal chamber and is disposed one of substantially coplanar with and slightly bulging outward relative to a surrounding rim 422 of the single access opening prior to/after docking of a male luer connector. While not shown in cross-section, depressible member 440 is also sized and otherwise adapted to facilitate defection, or bowing, within the internal chamber of the holding receptacle 420 upon docking of a nozzle of a male luer connector within the single access opening to the internal chamber 420. Such functionality may be provided in the same manner as described in relation to the docking apparatus 310 of
The docking apparatus 410 may also include a lateral handling member 462 having corner legs 464 interconnected thereto. The lateral handling member 462 extends laterally away from opposing sides of the holding receptacle 420 to facilitate grasping and manipulate of the docking apparatus 410. Additionally, side-bars 463 may be provided on the holding receptacle 420, wherein edge slots 474 are defined between the lateral handling member 462 and side-bars 463 of docking apparatus 410. Edge slots 474 may be utilized for selective interconnection of the docking apparatus 410 to a tubing line at a patient site. For such purposes, the docking apparatus 410 may further include leg slots 472 which are defined between opposing legs 464 and which further extend through the lateral handling member 460. Each of the various slots 472 and 474 may be sized for retention of a tubing line and beveled and/or tapered to facilitate non-occlusive interconnections.
As further shown by
Referring now to
In view of the foregoing embodiments, it will be appreciated that an overall method for use in conjunction with medical liquid administration is facilitated. To describe such method, reference is now made to the method embodiment 200 illustrated in
As shown, method embodiment 200 may include the initial step of unpackaging and setting up a medical liquid source and tubing line set (step 200). By way of example, the medical liquid source and tubing line set may comprise a vessel (e.g. a bag, syringe or vial) containing a medical liquid (e.g. liquid medication or flush solution), and a tubing length interconnected or interconnectable to the vessel at a proximal end and having a male luer connector at a distal end. In another arrangement, the tubing line set may further include a separate means for transferring liquid from the vessel through the tubing length.
Next, the medical liquid source may be interconnected to an access port to the vascular system of a patient (step 204). More particularly, a vascular catheter may be inserted into the vein of a patient and provided with an interconnected access port in the form of a female luer connector (e.g. preferably a swabbable type). Such female luer connector end may then be selectively interconnected with a male luer connector of the tubing line set that is interconnected with the medical liquid source. Upon such interconnection, medical liquid may be administered through the male luer connector end and female luer connector end into the patient via the vascular catheter (step 206).
After a desired amount of medical liquid has been administered, the male luer connector may be selectively disconnected from the access port (step 208). Prior to or in conjunction with such disconnection, a docking apparatus as described above may be removed from sterile packaging (step 210). Further, such docking apparatus may be supportably attached to a tubing line at the patient care site (step 212). Such attachment may entail the routing of the tubing line through one or more slots of the docking apparatus as noted above. Then, prior to docking the male luer connector with the docking apparatus, an anti-bacterial material (ABM) may be applied to a top surface of a depressible member presented by the docking apparatus (step 214).
In docking the male luer connector, the connector and docking apparatus may be aligned and advanced towards each other so that the nozzle of the male luer connector contacts the ABM on the top surface of the docking apparatus (step 216). The male luer connector and docking apparatus may then be interconnected (e.g. via threaded engagement) to isolate the nozzle of the male luer connector end within the holding receptacle of the docking apparatus (step 218).
Additional medical liquid may be administering via disconnection of the male luer connector and docking apparatus (steps 220 and 222), and repetition of steps 206, 208, 214, 216, and 218 noted above. This sequence may be further repeated as desired. In conjunction with such procedure, the ABM may be applied to the noted vascular catheter access port prior to each interconnection thereof with the male luer connector of the tubing line set.
Of note, the same docking apparatus may be employed in conjunction with each repeated sequence of medical liquid administration and male luer connector docking, thereby avoiding the need for separate capping procedures after each use of the male luer connector. Upon depletion of a given medical liquid source or after a predetermined period of time-in-use a given medical liquid source and/or tubing line set may be selectively disposed. Further, prior to or upon completion of the medical liquid therapy for a given patient the docking apparatus may be disposed (step 224).
The embodiments described above are for exemplary purposes only and are not intended to limit the scope of the present invention. Various adaptations, modifications and extensions will be apparent to those skilled in the art. For example, certain aspects of the present invention may be implemented in a further simplified embodiment which includes a cylindrical holding receptacle having a depressible member restrainably disposed therein. One end of the holding receptacle may be provided with external threads (e.g. for male luer interconnection). The other end may be interconnected via internal or external threading to a cap member having complementary threading, thereby defining an internal chamber with a single access opening.
Such embodiment as well as others are intended to be within the scope of the invention as defined by the claims which follow.
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|International Classification||A61M25/16, A61M39/20, A61M39/02, A61M39/18, A61M39/26|
|Cooperative Classification||A61M39/18, A61M39/26, A61M39/20, A61M39/02|
|Jun 7, 2010||AS||Assignment|
Owner name: BAXA CORPORATION,COLORADO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TIGHE, GERRY;BALDWIN, BRIAN EUGENE;RANALLETTA, JOSEPH V.;SIGNING DATES FROM 20020820 TO 20020821;REEL/FRAME:024496/0372
Owner name: BAXA CORPORATION, COLORADO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TIGHE, GERRY;BALDWIN, BRIAN EUGENE;RANALLETTA, JOSEPH V.;SIGNING DATES FROM 20020820 TO 20020821;REEL/FRAME:024496/0372
|Aug 2, 2013||AS||Assignment|
Owner name: BAXTER CORPORATION ENGLEWOOD, COLORADO
Free format text: CHANGE OF NAME;ASSIGNOR:BAXA CORPORATION;REEL/FRAME:030954/0603
Effective date: 20130101
|Jun 25, 2014||FPAY||Fee payment|
Year of fee payment: 4